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Intrapartum non-invasive electrophysiological monitoring: F2-study.


- candidate number28675
- NTR NumberNTR7064
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-mrt-2018
- Secondary IDsNL63732.015.17 
- Public TitleIntrapartum non-invasive electrophysiological monitoring: F2-study.
- Scientific TitleNon-invasive electrophysiological monitoring: F2-study
- ACRONYMF2-study
- hypothesisSince there is much debate about the poor specificity of the cardiotocogram (CTG), additional techniques for fetal surveillance during labour have been developed. The disadvantage of these techniques, such as fetal blood sampling (FBS) and ST-analysis of the fetal electrocardiogram (ECG; STAN), is that they are invasive and can only be performed when membranes have ruptured. Non-invasive fetal ECG (NI-fECG) monitoring can overcome these disadvantages, by providing both an accurate fetal heart rate (FHR) and information on the fetal ECG morphology, both in a non-invasive way.
- Healt Condition(s) or Problem(s) studiedLabour, Fetal monitoring
- Inclusion criteriaPregnant women who are in labour, carrying a healthy, singleton fetus in cephalic presentation, with a gestational age between 37 and 42 weeks
- Exclusion criteria- < 18 years of age
- Multiple pregnanc y
- Fetus in breech pos ition
- Women with signs of feta l distress (abnormal CTG requiring immediate intervention)
- Women with a positive hepatitis B/C or HIV serology
- Women with idiopathic thrombocytopenia or other inh eritable hematologic diseases
- Dermatologic disease of the abdomen precluding preparation of the abdomen with a brasive paper - Women in labour taking a shower or bath and women connected to external or implanted electrical stimulators
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 15-feb-2018
- planned closingdate31-mei-2018
- Target number of participants120
- InterventionsIn addition to standard intrapartum monitoring by fetal scalp electrode (FSE) with tocodynamometer, eligible patients will also receive a transabdominal, non-invasive fECG patch, from the moment of start of fetal monitoring until the end of delivery. Also, at several moments during labour fetal position will be checked by short ultrasound measurements.
- Primary outcomeThe main goal of this validation study is to assess accuracy and reliability of monitoring of the fetal heart rate (FHR) by non-invasive fetal ECG (NI-fECG) using the Atlantis/Parides device. Since conduction of electrical signals may depend on the presence of amniotic fluid, we aim to study both FHR measurements in (part of) the period before membranes have (been) ruptured (in comparison to Doppler ultrasound (DU)), as well as after membranes have (been) ruptured (in comparison to the fetal scalp electrode (FSE, gold standard)).
- Secondary outcomeSince there is much information to be collected by non-invasive electrophysiological monitoring by the Atlantis/Parides system, there are several secondary objectives.
First, we aim to validate the monitoring of maternal heart rate (MHR) measured by the Atlantis/Parides system as compared to standard methods of monitoring maternal heart rate during labour (for instance pulse oximetry or the pulse Doppler signal provided by the TOCO button). Correct monitoring of maternal heart rate during labour is important since this maternal signal needs to be filtered out of the fetal signal, in order to obtain a reliable fetal ECG signal. From a clinical point of view, it is of the utmost importance to simultaneously monitor both mother and fetus. In this way the clinician can be sure that the fetus is indeed being monitored, instead of only the mother, which is a dangerous pitfall of intrapartum fetal monitoring.

Second, we would like to compare the EHG signals retrieved by the Atlantis/Parides patch with the intrauterine pressure catheter (IUPC) and/or with the tocodynamometer (TOCO)), depending on local protocol. The latter in a descriptive manner. By comparing the EHG to IUPC we want to validate the EHG function of the Parides patch. Further we want to explore the possibility to calculate the (relative) pressure of the contractions with the EHG.
- TimepointsDuring labour.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Carlijn Lempersz
- CONTACT for SCIENTIFIC QUERIES Lore Noben
- Sponsor/Initiator Maxima Medical Center, Veldhoven
- Funding
(Source(s) of Monetary or Material Support)
European grant Horizon 2020
- Publications
- Brief summaryRationale: Since there is much debate about the poor specificity of the cardiotocogram (CTG), additional techniques for fetal surveillance during labour have been developed. The disadvantage of these techniques, such as fetal blood sampling (FBS) and ST-analysis of the fetal electrocardiogram (ECG; STAN), is that they are invasive and can only be performed when membranes have ruptured. Non-invasive fetal ECG (NI-fECG) monitoring can overcome these disadvantages, by providing both an accurate fetal heart rate (FHR) and information on the fetal ECG morphology, both in a non-invasive way.
Objective: This study aims to validate NI-fECG monitoring as an accurate and reliable monitoring technique for fetal surveillance during labour. The aim of this validation is to work towards clinical implementation of NI-fECG monitoring.
Study design: This study is designed as a cross-sectional observational study, with a prospective nature.
Study population: Pregnant women who are in labour, carrying a healthy, singleton fetus in cephalic presentation, with a gestational age between 37 and 42 weeks. We aim to include 100 patients.
Intervention (if applicable): In addition to standard intrapartum monitoring by fetal scalp electrode (FSE) with tocodynamometer, eligible patients will also receive a transabdominal, non-invasive fECG patch, from the moment of start of fetal monitoring until the end of delivery. Also, at several moments during labour fetal position will be checked by short ultrasound measurements.
Main study parameters/endpoints: The main endpoint of this study is to assess the accuracy and reliability of the NI-fECG monitorings for FHR and MHR. This will be compared to the accuracy of the gold standard FSE monitoring and pulse oximetry, respectively. Electrohysterogram (EHG) signals retrieved by the non-invasive fECG patch will be analysed and compared with the tocodynamometer/intrauterine pressure catheter (IUPC). Furthermore, fECG waveform details will be analysed and relevant information will be correlated to several clinical maternal and fetal parameters..
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in this validation study will cause no risk for the patient. There is a very small chance that participating patients experience skin irritation or a minor allergic (local) reaction to the skin electrodes from the NI-fECG patch.
- Main changes (audit trail)
- RECORD5-mrt-2018 - 13-mrt-2018


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